Lung Diseases, Lung Diseases, Interstitial, Pulmonary Fibrosis, Respiratory Tract Diseases
Conditions
Keywords
Idiopathic Pulmonary Fibrosis, Interferon alpha
Brief summary
The purpose of this study is to determine the possible efficacy of low dose, orally administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).
Detailed description
This is a pilot study to determine if oral administration of low doses of Interferon alpha might be effective in treating Idiopathic Pulmonary Fibrosis (IPF). This is a disease that damages the lungs leading to marked decreases in the quality of life and death within 3-5 years after diagnosis. The cause is unknown. The standard treatment has for some time been steroids such as prednisone or prednisolone because of their anti-inflammatory actions, but there is little evidence that steroids either improve the condition, prevent further deterioration or improve life expectancy. Additionally, they have many side effects. In this disease, normal cells are damaged for unknown reasons and replaced by a type of scar. This scar tissue prevents the easy movement of oxygen from the lungs into the blood, making it difficult for the patient to perform normal activities. With progression, which usually occurs rapidly, patients require supplemental oxygen to perform even simple tasks. Interferons are chemicals normally produced in the body and the rate of their production has been shown to be reduced in the lungs of patients with IPF. They are involved in regulating the activity of the immune system which may play a role in initiating the damage to the lungs in IPF and they also can inhibit the activity of the cells that form the scar tissue. Our hypothesis is that treating patients with interferon might prevent damage to additional normal tissue and prevent the formation of additional scar tissue. This would prevent progression, improve the quality of life and extend the expected life span if successful. Another study has been ongoing in which IPF patients have been given injections of large doses of another type of interferon. This treatment regimen is expensive and side effects have been fairly frequent. In contrast, we are treating IPF patients with low doses of interferon administered orally. The interferon is taken three times per day by letting a lozenge dissolve in the mouth. These low doses have been shown to produce effects in patients with other diseases and they produce very few side effects. If side effects occur, they usually are not severe and go away quickly. Those reported most commonly by other subjects have been headaches, nausea, rashes, respiratory infections, sore throat or diarrhea. No one has had to stop taking the medicine because of the side effects. The medicine is provided free of charge. This study has been going on for about 5 years. The subjects are given the same tests that they receive as part of their standard of care. These include chest x-rays, High Resolution CT scans, pulmonary function tests and some blood tests. They are done before starting interferon alpha, and, depending on the test, are repeated at 3-, 6-, 9- or 12 month intervals. In addition subjects are asked to complete questionnaires on the quality of life, cough history and a dyspnea index at each visit.
Interventions
DRUGInterferon alpha oral lozenge
dose form - oral lozenge dose - 150 International Units (IU) frequency - 3 times a day duration - at least 1 year
Sponsors
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Texas Tech University Health Sciences Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The only subjects to be included in this study are those diagnosed with Idiopathic Pulmonary Fibrosis with diagnosis based on the criteria published by the American Thoracic Society in the International Consensus Statement. 1. Exclusion of other known causes of interstitial lung disease. 2. Abnormal pulmonary function studies. 3. Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT scan. 4. Biopsy or lavage showing no features supporting alternative diagnosis. 5. Patient older than 50 years of age. 6. Insidious onset of otherwise unexplained dyspnea on exertion. 7. Duration greater than 3 months. 8. Bibasilar, inspiratory crackles.
Exclusion criteria
* under the age of 50 * history of hypersensitivity to interferons * history of hypersensitivity to biological products such as vaccines * pregnant or lactating women * women of child bearing age not pregnancy protected during the study * unresolved serious cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function | 1 yr | Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT & pulmonary function. The same radiologist did the comparsion for all subjects. |
| Minimal/no Change in Quality of Life | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Change in Cough | 1 month | changes in cough status after treatment for 1 month. |
Countries
United States
Participant flow
Recruitment details
Medical clinic
Participants by arm
| Arm | Count |
|---|---|
| Interferon Alpha Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Non-compliance | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Interferon Alpha |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age Continuous | 67 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 4 / 18 |
Outcome results
Primary
Minimal/no Change in Quality of Life
Time frame: 12 months
Population: Analysis was performed only on those subject who continue on medication for at least one year.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interferon Alpha | Minimal/no Change in Quality of Life | 12 Participants |
Primary
Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function
Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT & pulmonary function. The same radiologist did the comparsion for all subjects.
Time frame: 1 yr
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interferon Alpha | Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function | 12 Participants |
Secondary
Participants With Change in Cough
changes in cough status after treatment for 1 month.
Time frame: 1 month
Population: During the course of the study it was noted that subjects experienced a change in the cough that is sometimes associated with IPF. The 6 subjects still enrolled in the study were asked to complete a questionnare regarding the status of the cough.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interferon Alpha | Participants With Change in Cough | 5 Participants |